Category Archives: Recalled Medical Devices

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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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Actos Bladder Cancer Lawsuit Filed by West Virginia Resident

Actos (pioglitazone) continues to be named in lawsuits alleging long-term use of the type 2 diabetes drug caused patients to develop bladder cancer. Just last week, the national law firm of Parker Waichman LLP filed suit against Takeda Pharmaceuticals on behalf of a West Virginia man who developed bladder cancer ...

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Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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Post -Tonsillectomy Morphine Life-Threatening in Children

Post -Tonsillectomy Morphine can be Life-Threatening in Children, Study Finds

A new study published in Pediatrics suggests that morphine can result in life-threatening respiratory problems when given to children after a tonsillectomy.

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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Study Links Liquid in E-Cigarette to Viral Infections

Study Links Liquid in Electronic Cigarette to Increased Risk of Viral Infections

The National Jewish Health study, links the liquid used in e-cigarettes to a higher risk of respiratory viral infections, whether the liquid contains nicotine or not.

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Boston Scientific Recalls Fetch 2 Aspiration Catheters

Boston Scientific has recalled all models of the Fetch 2 Aspiration Catheter. The U.S. Food and Drug Administration (FDA) has classified this as a Class 1 recall, the most serious type of recall where the FDA deems a reasonable probability … Continue reading

Posted in Defective Medical Devices, Health Concerns, Recalled Medical Devices |

Jurors Hear Expert Testimony in DePuy Pinnacle Trial

J&J-Trial

The bellwether trial over injuries allegedly caused by the DePuy Pinnacle metal-on-metal hip implant continues in the Northern District of Texas. For the past four weeks, jurors have been hearing arguments over whether the hip replacements are to blame for … Continue reading

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Arkray Recalls Glucose Test Strips Because of Inaccurate Readings

Arkray-Recalls-Glucose-Test-Strips

Arkray USA, which makes products for diabetes management, has announced the recall of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip used to test blood sugar (glucose) levels in patients with diabetes because these … Continue reading

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Texas Woman Sues 3M over Defective Surgical Warming Device

A Texas woman has sued 3M, accusing the company of selling defective surgical equipment responsible for a drug-resistant infection that led to a leg amputation. This case is the latest in a series of cases that argue 3M’s patient-warming Bair … Continue reading

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Hamilton-G5 Ventilator under Second Class 1 Recall This Year

Hamilton-G5 Ventilator Under Second Class 1 Recall

Hamilton Medical has issued a recall of more than 1,100 Hamilton-G5 ventilators because a software problem can unintentionally suppress ventilation alarms. The recall, posted on November 4, is the second Class 1 recall of Hamilton Medical ventilators this year, FierceMedicalDevices … Continue reading

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Baxter Vascular Patch Recalled over Difficulty Distinguishing Proper Orientation for Use

Packaging Caused Class I Recall of Peripheral Vascular Patch

After customer complaints of difficulties distinguishing the smooth from the rough surface of the Vascu-Guard Peripheral Vascular Patch, Baxter International has announced the voluntary recall of four product codes of the vascular patch. The Vascu-Guard Peripheral Vascular Patch is intended … Continue reading

Posted in Defective Medical Devices, Health Concerns, Recalled Medical Devices |

FDA Class I Recall for TigerPaw II Heart Device

FDA Class I Recall for TigerPaw II Heart Device

On May 7, 2015, the U.S. Food and Drug Administration (FDA) announced the recall of the TigerPaw System II by Maquet Medical Systems. The TigerPaw II is an implantable left atrial appendage (LAA) occlusion device meant for use during heart … Continue reading

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Kraft Foods Recalls Macaroni & Cheese Dinner Due to Possible Metal Pieces

Kraft Foods Recalls Macaroni & Cheese Dinner

Kraft Foods Group has voluntarily recalled approximately 242,000 cases of Original flavor Kraft Macaroni & Cheese Dinner because some boxes may contain small pieces of metal. The recall is limited to the 7.25-oz. size of the Original flavor with “Best … Continue reading

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Stryker Hip Settlement Enrollment Deadline Extended

Stryker Hip Settlement Enrollment Deadline Extended

The deadline for hip implant recipients to enroll in the Stryker Orthopaedics Rejuvenate Hip System settlement has been extended to March 30, 2015. Patients who received a recalled ABG II Modular Hip System or Rejuvenate Modular Hip System still have … Continue reading

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Stryker Settles Hip Implant Cases at Expected Cost of $1 Billion

Stryker, a major manufacturer of hip replacement devices, said on Monday that it had reached a settlement in thousands of lawsuits involving now-recalled all-metal hip devices. The settlement could cost the company about $1 billion. The deal would represent one … Continue reading

Posted in Defective Medical Devices, Depuy, Health Concerns, Metal Hip Implants, Recalled Medical Devices |

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